- Preliminary results from a Phase 3 clinical trial, ALCYONE, assessing Johnson & Johnson unit (JNJ -0.3%) Janssen Biotech's DARZALEX (daratumumab), in combination with Takeda's VELCADE (bortezomib) and melphalan-prednisone, in treatment-naive multiple myeloma patients showed a statistically valid increase in progression-free survival (PFS) compared to Velcade and melphalan-prednisone (VMP) alone.
- The pre-planned interim analysis showed the addition of DARZALEX reduced the risk of cancer progression or death by 50%. Median PFS in the DARZALEX group has not been reached. Median PFS in patients treated with VMP alone was estimated to be 18.1 months.
- The Independent Data Monitoring Committee has recommended that the data be unblinded. All participants will continue to be followed for safety and overall survival. The data will be submitted for presentation at a future medical conference and for publication.
- Janssen licensed daratumumab from Genmab A/S (OTCPK:GNMSF)(OTCPK:GMXAY) in 2012.
- Genmab maintains its 2017 guidance.
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Original article